FDA expectations continue to evolve across medical devices, drugs, biologics and combination products. For CMC, Quality, Regulatory Affairs, Manufacturing and Compliance professionals, understanding how standards, quality systems and inspection expectations connect is essential to building effective development and manufacturing programs.
This program brings together FDA representatives, industry leaders, testing laboratories and former FDA professionals for a practical discussion spanning the product lifecycle.
The program is structured around three questions:
- What evidence does FDA rely on?
Explore FDA-recognized consensus standards, conformity assessment, the ASCA program roadshow, testing laboratories and the role of reliable quality evidence in regulatory decision-making. - How do companies build systems that consistently generate that evidence?
Examine how companies establish sustainable quality systems across medical devices, drugs, biologics and combination products. Topics include QMSR, ISO 13485, MDSAP, 21 CFR Part 4, CAPA, change management, risk-based quality management, manufacturing controls and lifecycle management. - How does FDA verify those systems during an inspection?
Hear directly from FDA inspection professionals about inspection approaches, investigator expectations, common observations, inspection readiness and compliance considerations across medical devices, drugs and biologics. This session will include a hands-on workshop based on an industry case study
The full-day event will combine expert presentations with moderated discussion, workshop and audience Q&A, giving attendees an opportunity to engage directly with FDA and industry speakers.
Who should attend
- CMC professionals
- Quality and Quality Systems professionals
- Regulatory Affairs professionals
- Manufacturing and Operations leaders
- Compliance and inspection readiness professionals
- Medical device professionals
- Pharmaceutical and biologics professionals
- Cell and gene therapy professionals
- Combination product professionals
- CDMO and contract testing professionals
Why attend
Gain practical perspectives on how regulatory evidence, quality systems, manufacturing practices and FDA inspections connect. The program is designed to help professionals strengthen quality strategies, improve inspection readiness and better understand FDA expectations across different product categories.
Agenda
*Full agenda and speaker lineup coming soon!
Location
Gilead Sciences
323 Vintage Park Dr
Foster City, CA 94404
Parking instructions: Parking is free and available either around the building or across the street in the multi-story parking garage in front of Building 309 (309 Velocity Way).
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
